Glaxo refuses settlement in U.K. Avandia diabetes casesDespite settling U.S. lawsuits over claims that the diabetes drug Avandia causes heart attacks and strokes, GlaxoSmithKline has decided to fight similar claims in the U.K. It has become “increasingly difficult in the U.K. to challenge large corporations such as pharmaceutical companies," said Liz Thomas, policy manager at the patient-safety charity Action against Medical Accidents. Pharmalot.com/Pharma blog
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Europe

EMA to consider blood clot risks of newer contraceptivesThe European Medicines Agency will review third- and fourth-generation combined oral contraceptives' safety to decide if restricting their use is necessary. The move was requested by France, which wants to limit the newer contraceptives' use due to blood clots. "There is no reason for any woman to stop taking her contraceptive," the EMA said. "If a woman has concerns, she can discuss this with her doctor." Reuters
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,PharmaTimes (U.K.)
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U.K. drugmakers and physicians call for transparency in financial tiesA coalition of British physicians and pharmaceutical companies have created a template for disclosing payments and other financial ties between drugmakers and doctors as the U.K. works toward greater transparency. Similar efforts are under way in the U.S. and France. The effort is to find "whether there is, in principle, support for a publicly available, single, searchable system for disclosure of payments," said Richard Thompson, president of the Royal College of Physicians. Pharmalot.com
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Drug industry group disputes lowering cost-effectiveness thresholdsLowering the current threshold of quality-adjusted life years, or QALYs, for assessing the cost effectiveness of new drugs and medicines would deny such medications to thousands and lead to a decline in U.K. health standards, according to the Association of the British Pharmaceutical Industry. The group was responding to a study by University of York health economists who said the current standard "is not based on evidence" and should be reduced. PharmaTimes (U.K.)
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Asia Pacific

Malaysia issues final regulations for medical devicesThe Malaysian government has published comprehensive regulations for medical devices, covering such areas as registration, licensing, export permits and procedures for appealing decisions. The effective date is July 1, with a two-year transition period for devices already on the market. Clinica
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Few migraine medications for adults are effective in childrenData from 21 trials of migraine drugs for adults showed that only topiramate and trazodone significantly reduced the frequency of headaches among children and teens who experience regular migraines. Placebos alone yielded good outcomes in children, effectively reducing headaches per month from between five to six to just three, researchers reported in the journal JAMA Pediatrics. Reuters
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Statins linked with lower mortality risk in study of liver cancerPatients with hepatocellular carcinoma who took statins, in combination with local and systemic treatments or surgical resection, had a 30% lower risk of death than non-statin users. Statin users lived for an average of 25.4 months compared with 18.5 for non-users, researchers said. The retrospective, nonrandomized study, which involved 644 patients, was presented at the Gastrointestinal Cancers Symposium. MedPage Today (free registration)
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Global

Indian drugmakers filed most DMFs in 2012Drugmakers from India submitted more drug master files with the FDA than companies from any other nation. The files are required for the third-party sale of drug ingredients in the U.S. Indian drugmakers filed 70 DMFs out of a total 143 in one quarter. Sun Pharmaceutical Industries, Lupin Pharmaceuticals and Dr. Reddy's Laboratories were among the top filers for the year. Business Standard (India)
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It’s not getting any easier to comply with all the regulatory and legal requirements that apply to marketing pharmaceuticals and medical devices. Wayne L. Pines, president, regulatory services and healthcare at APCO Worldwide, Inc., highlights key recent FDA enforcement actions to be discussed at the Marketing Pharmaceuticals Workshop next month: “The recent letters that OPDP issued regarding press materials are certain to be of great interest. In particular, the letter that dealt with a ‘pitch’ letter was very interesting and should engender questions.” Read more.